Collateral ventilation bypass trap system

ABSTRACT

A long term oxygen therapy system having an oxygen supply directly linked with a patient&#39;s lung or lungs may be utilized to more efficiently treat hypoxia caused by chronic obstructive pulmonary disease such as emphysema and chronic bronchitis. The system includes an oxygen source, one or more valves and fluid carrying conduits. The fluid carrying conduits link the oxygen source to diseased sites within the patient&#39;s lungs. A collateral ventilation bypass trap system directly linked with a patient&#39;s lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating another aspect of chronic obstructive pulmonary disease. The system includes a trap, a filter/one-way valve and an air carrying conduit.

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. ProvisionalApplication Serial No. 60/406,624 filed on Aug. 28, 2002.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to systems and methods for removingtrapped air in emphysematous lungs, and more particularly, to systemsand methods for removing trapped air in emphysematous hyperinflatedlungs by bypassing non-patent airways via a conduit through the outerpleural layer of the lung to a containment/trap device.

[0004] 2. Discussion of the Related Art

[0005] As a result of studies that date back to the 1930's andparticularly studies conducted in the 1960's and early 1970's, it hasbeen determined that long-term continuous oxygen therapy is beneficialin the treatment of hypoxemic patients with chronic obstructivepulmonary disease. In other words, a patient's life and quality of lifecan be improved by providing a constant supplemental supply of oxygen tothe patient's lungs.

[0006] However, with the desire to contain medical costs, there is agrowing concern that the additional cost of providing continuous oxygentherapy for chronic lung disease will create an excessive increase inthe annual cost of oxygen therapy. Thus, it is desirable that oxygentherapy, when provided, be as cost effective as possible.

[0007] The standard treatment for patients requiring supplemental oxygenis still to deliver oxygen from an oxygen source by means of a nasalcannula. Such treatment, however, requires a large amount of oxygen,which is wasteful and can cause soreness and irritation to the nose, aswell as being potentially aggravating. Other undesirable effects havealso been reported. Various other medical approaches which have beenproposed to help reduce the cost of continuous oxygen therapy have beenstudied.

[0008] Various devices and methods have been devised for performingemergency cricothyroidotomies and for providing a tracheotomy tube sothat a patient whose airway is otherwise blocked may continue to breath.Such devices are generally intended only for use with a patient who isnot breathing spontaneously and are not suitable for the long termtreatment of chronic lung disease. Typically, such devices are installedby puncturing the skin to create a hole into the cricoid membrane of thelarynx above the trachea into which a relatively large curvedtracheotomy tube is inserted. As previously described, the use of suchtubes has been restricted medically to emergency situations where thepatient would otherwise suffocate due to the blockage of the airway.Such emergency tracheotomy tubes are not suitable for long term therapyafter the airway blockage is removed.

[0009] Other devices which have been found satisfactory for emergency orventilator use are described in U.S. Pat. No. 953,922 to Rogers; U.S.Pat. No. 2,873,742 to Shelden; U.S. Pat. No. 3,384,087 to Brummelkamp;U.S. Pat. No. 3,511,243 to Toy; U.S. Pat. No. 3,556,103 to Calhoun; U.S.Pat. No. 2,991,787 to Shelden, et al; U.S. Pat. No. 3,688,773 to Weiss;U.S. Pat. No. 3,817,250 to Weiss, et al.; and U.S. Pat. No. 3,916,903 toPozzi.

[0010] Although tracheotomy tubes are satisfactory for their intendedpurpose, they are not intended for chronic usage by outpatients as ameans for delivering supplemental oxygen to spontaneously breathingpatients with chronic obstructive pulmonary disease. Such tracheotomytubes are generally designed so as to provide the total air supply tothe patient for a relatively short period of time. The tracheotomy tubesare generally of rigid or semi-rigid construction and of caliber rangingfrom 2.5 mm outside diameter in infants to 15 mm outside diameter inadults. They are normally inserted in an operating room as a surgicalprocedure or during emergency situations, through the crico-thyroidmembrane where the tissue is less vascular and the possibility ofbleeding is reduced. These devices are intended to permit passage of airin both directions until normal breathing has been restored by othermeans.

[0011] Another type of tracheotomy tube is disclosed in Jacobs, U.S.Pat. Nos. 3,682,166 and 3,788,326. The catheter described therein isplaced over 14 or 16 gauge needle and inserted through the crico-thyroidmembrane for supplying air or oxygen and vacuum on an emergency basis torestore the breathing of a non-breathing patient. The air or oxygen issupplied at 30 to 100 psi for inflation and deflation of the patient'slungs. The Jacobs catheter, like the other tracheotomy tubes previouslyused, is not suitable for long term outpatient use, and could not easilybe adapted to such use.

[0012] Due to the limited functionality of tracheotomy tubes,transtracheal catheters have been proposed and used for long termsupplemental oxygen therapy. For example the small diametertranstracheal catheter (16 gauge) developed by Dr. Henry J. Heimlich(described in THE ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY,November-December 1982; Respiratory Rehabilitation with TranstrachealOxygen System) has been used by the insertion of a relatively largecutting needle (14 gauge) into the trachea at the mid-point between thecricothyroid membrane and the sternal notch. This catheter size cansupply oxygen up to about 3 liters per minute at low pressures, such as2 psi which may be insufficient for patients who require higher flowrates. It does not, however, lend itself to outpatient use andmaintenance, such as periodic removal and cleaning, primarily becausethe connector between the catheter and the oxygen supply hose isadjacent and against the anterior portion of the trachea and cannot beeasily seen and manipulated by the patient. Furthermore, the catheter isnot provided with positive means to protect against kinking orcollapsing which would prevent its effective use on an outpatient basis.Such a feature is not only desirable but necessary for long termoutpatient and home care use. Also, because of its structure, i.e. onlyone exit opening, the oxygen from the catheter is directed straight downthe trachea toward the bifurcation between the bronchi. Because of thenormal anatomy of the bronchi wherein the left bronchus is at a moreacute angle to the trachea than the right bronchus, more of the oxygenfrom that catheter tends to be directed into the right bronchus ratherthan being directed or mixed for more equal utilization by both bronchi.Also, as structured, the oxygen can strike the carina, resulting in anundesirable tickling sensation and cough. In addition, in such devices,if a substantial portion of the oxygen is directed against the back wallof the trachea causing erosion of the mucosa in this area which maycause chapping and bleeding. Overall, because of the limited output fromthe device, it may not operate to supply sufficient supplemental oxygenwhen the patient is exercising or otherwise quite active or has severedisease.

[0013] Diseases associated with chronic obstructive pulmonary diseaseinclude chronic bronchitis and emphysema. One aspect of an emphysematouslung is that the communicating flow of air between neighboring air sacsis much more prevalent as compared to healthy lungs. This phenomenon isknown as collateral ventilation. Another aspect of an emphysematous lungis that air cannot be expelled from the native airways due to the lossof tissue elastic recoil and radial support of the airways. Essentially,the loss of elastic recoil of the lung tissue contributes to theinability of individuals to exhale completely. The loss of radialsupport of the airways also allows a collapsing phenomenon to occurduring the expiratory phase of breathing. This collapsing phenomenonalso intensifies the inability for individuals to exhale completely. Asthe inability to exhale completely increases, residual volume in thelungs also increases. This then causes the lung to establish in ahyperinflated state where an individual can only take short shallowbreaths. Essentially, air is not effectively expelled and stale airaccumulates in the lungs. Once the stale air accumulates in the lungs,the individual is deprived of oxygen.

[0014] Currently, treatments for chronic obstructive pulmonary diseaseinclude bronchodilating drugs, oxygen therapy as described above, andlung volume reduction surgery. Bronchodilating drugs only work on apercentage of patients with chronic obstructive pulmonary disease andgenerally only provides short term relief. Oxygen therapy is impracticalfor the reasons described above, and lung volume reduction surgery is anextremely traumatic procedure that involves removing part of the lung.The long term benefits of lung volume reduction surgery are not fullyknown.

[0015] Accordingly, there exists a need for increasing the expiratoryflow from an individual suffering from chronic obstructive pulmonarydisease.

SUMMARY OF THE INVENTION

[0016] The present invention overcomes the disadvantages associated withtreating chronic obstructive pulmonary disease, as briefly describedabove, by utilizing the phenomenon of collateral ventilation to increasethe expiratory flow from a diseased lung.

[0017] In accordance with one aspect, the present invention is directedto a collateral ventilation bypass trap system. The collateralventilation bypass trap system comprises a containment vessel forcollecting discharge from one or more lungs of a patient, at least oneconduit having a first end connected to the containment vessel and asecond end passing through the thoracic wall and lung of a patient at apredetermined site, thereby establishing fluid communication between thecontainment vessel and the inner volume of the lung, and a sealingdevice for establishing a fluid tight seal between the at least oneconduit and the thoracic wall and between the at least one conduit andthe lung.

[0018] In accordance with another aspect, the present invention isdirected to a collateral ventilation bypass trap system. The collateralventilation bypass trap system comprises a containment vessel forcollecting discharge from one or more lungs of a patient, afilter/one-way valve connected to the containment vessel, at least oneconduit having a first end connected to the containment vessel throughthe filter/one-way valve and a second end passing through the thoracicwall and lung of a patient at a predetermined site, thereby establishingfluid communication between the containment vessel and the inner volumeof the lung, and a sealing device for establishing a fluid tight sealbetween the at least one conduit and the thoracic wall and between theat least one conduit and the lung.

[0019] In accordance with another aspect, the present invention isdirected to a method for increasing the expiratory flow from a diseasedlung. The method comprises creating an anastomotic opening extendingfrom the thoracic wall and into the inner volume of the lung at a sitedetermined to have a high degree of collateral ventilation, establishinga fluid communication link between the inner volume of the lung at thesite determined to have a high degree of collateral ventilation and acontainment vessel through a conduit extending from the containmentvessel to the lung through the anastomotic opening such that air in thelung flows into the containment vessel, and establishing a fluid tightseal between the anastomotic opening and the conduit.

[0020] The long term oxygen therapy system of the present inventiondelivers oxygen directly to diseased sites in a patient's lungs. Longterm oxygen therapy is widely accepted as the standard treatment forhypoxia caused by chronic obstructive pulmonary disease, for example,pulmonary emphysema. Pulmonary emphysema is a chronic obstructivepulmonary disease wherein the alveoli of the lungs lose their elasticityand the walls between adjacent alveoli are destroyed. As more and morealveoli walls are lost, the air exchange surface area of the lungs isreduced until air exchange becomes seriously impaired. The combinationof mucus hypersecretion and dynamic air compression is a mechanism ofairflow limitation in chronic obstructive pulmonary disease. Dynamic aircompression results from the loss of tethering forces exerted on theairway due to the reduction in lung tissue elasticity. Essentially,stale air accumulates in the lungs, thereby depriving the individual ofoxygen. Various methods may be utilized to determine the location orlocations of the diseased tissue, for example, computerized axialtomography or CAT scans, magnetic resonance imaging or MRI, positronemission tomograph or PET, and/or standard X-ray imaging. Once thelocation or locations of the diseased tissue are located, anastomoticopenings are made in the thoracic cavity and lung or lungs and one ormore oxygen carrying conduits are positioned and sealed therein. The oneor more oxygen carrying conduits are connected to an oxygen source whichsupplies oxygen under elevated pressure directly to the diseased portionor portions of the lung or lungs. The pressurized oxygen essentiallydisplaces the accumulated air and is thus more easily absorbed by thealveoli tissue. In addition, the long term oxygen therapy system may beconfigured in such a way as to provide collateral ventilation bypass inaddition to direct oxygen therapy. In this configuration, an additionalconduit may be connected between the main conduit and the individual'strachea with the appropriate valve arrangement. In this configuration,stale air may be removed through the trachea when the individual exhalessince the trachea is directly linked with the diseased site or sites inthe lung via the conduits.

[0021] The long term oxygen therapy system of the present inventionimproves oxygen transfer efficiency in the lungs thereby reducing oxygensupply requirements, which in turn reduces the patient's medical costs.The system also allows for improved self-image, improved mobility,greater exercise capability and is easily maintained.

[0022] The above-described long term oxygen therapy system may beutilized to effectively treat hypoxia caused by chronic obstructivepulmonary disease; however, other means may be desirable to treat otheraspects of the disease. As set forth above, emphysema is distinguishedas irreversible damage to lung tissue. The breakdown of lung tissueleads to the reduced ability for the lungs to recoil. The tissuebreakdown also leads to the loss of radial support of the airways.Consequently, the loss of elastic recoil of the lung tissue contributesto the inability for individuals with emphysema to exhale completely.The loss of radial support of the airways also allows a collapsingphenomenon to occur during the expiratory phase of breathing. Thiscollapsing phenomenon also intensifies the inability for individuals toexhale completely. As the inability to exhale increases, residual volumein the lungs also increases. This then causes the lung to establish in ahyperinflated state wherein an individual can only take short shallowbreaths.

[0023] The collateral ventilation bypass trap system of the presentinvention utilizes the above-described collateral ventilation phenomenonto increase the expiratory flow from a diseased lung or lungs, therebytreating another aspect of chronic obstructive pulmonary disease.Essentially, the most collaterally ventilated area of the lung or lungsis determined utilizing the scanning techniques described above. Oncethis area or areas are located, a conduit or conduits are positioned ina passage or passages that access the outer pleural layer of thediseased lung or lungs. The conduit or conduits utilize the collateralventilation of the lung or lungs and allow the entrapped air to bypassthe native airways and be expelled to a containment system outside ofthe body.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The foregoing and other features and advantages of the inventionwill be apparent from the following, more particular description ofpreferred embodiments of the invention, as illustrated in theaccompanying drawings.

[0025]FIG. 1 is a diagrammatic representation of a first exemplaryembodiment of the long term oxygen therapy system in accordance with thepresent invention.

[0026]FIG. 2 is a diagrammatic representation of a first exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0027]FIG. 3 is a diagrammatic representation of a second exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0028]FIG. 4 is a diagrammatic representation of a third exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0029]FIG. 5 is a diagrammatic representation of a fourth exemplaryembodiment of a sealing device utilized in conjunction with the longterm oxygen therapy system of the present invention.

[0030]FIG. 6 is a diagrammatic representation of a second exemplaryembodiment of the long term oxygen therapy system in accordance with thepresent invention.

[0031]FIG. 7 is a diagrammatic representation of a first exemplaryembodiment of a collateral ventilation bypass trap system in accordancewith the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Air typically enters the mammalian body through the nostrils andflows into the nasal cavities. As the air passes through the nostrilsand nasal cavities, it is filtered, moistened and raised or lowered toapproximately body temperature. The back of the nasal cavities iscontinuous with the pharynx (throat region); therefore, air may reachthe pharynx from the nasal cavities or from the mouth. Accordingly, ifequipped, the mammal may breath through its nose or mouth. Generally airfrom the mouth is not as filtered or temperature regulated as air fromthe nostrils. The air in the pharynx flows from an opening in the floorof the pharynx and into the larynx (voice box). The epiglottisautomatically closes off the larynx during swallowing so that solidsand/or liquids enter the esophagus rather than the lower air passagewaysor airways. From the larynx, the air passes into the trachea, whichdivides into two branches, referred to as the bronchi. The bronchi areconnected to the lungs.

[0033] The lungs are large, paired, spongy, elastic organs, which arepositioned in the thoracic cavity. The lungs are in contact with thewalls of the thoracic cavity. In humans, the right lung comprises threelobes and the left lung comprises two lobes. Lungs are paired in allmammals, but the number of lobes or sections of lungs varies from mammalto mammal. Healthy lungs, as discussed below, have a tremendous surfacearea for gas/air exchange. Both the left and right lung is covered witha pleural membrane. Essentially, the pleural membrane around each lungforms a continuous sac that encloses the lung. A pleural membrane alsoforms a lining for the thoracic cavity. The space between the pleuralmembrane forming the lining of the thoracic cavity and the pleuralmembranes enclosing the lungs is referred to as the pleural cavity. Thepleural cavity comprises a film of fluid that serves as a lubricantbetween the lungs and the chest wall.

[0034] In the lungs, the bronchi branch into a multiplicity of smallervessels referred to as bronchioles. Typically, there are more than onemillion bronchioles in each lung. Each bronchiole ends in a cluster ofextremely small air sacs referred to as alveoli. An extremely thin,single layer of epithelial cells lining each alveolus wall and anextremely thin, single layer of epithelial cells lining the capillarywalls separate the air/gas in the alveolus from the blood. Oxygenmolecules in higher concentration pass by simple diffusion through thetwo thin layers from the alveoli into the blood in the pulmonarycapillaries. Simultaneously, carbon dioxide molecules in higherconcentration pass by simple diffusion through the two thin layers fromthe blood in the pulmonary capillaries into the alveoli.

[0035] Breathing is a mechanical process involving inspiration andexpiration. The thoracic cavity is normally a closed system and aircannot enter or leave the lungs except through the trachea. If the chestwall is somehow compromised and air/gas enters the pleural cavity, thelungs will typically collapse. When the volume of the thoracic cavity isincreased by the contraction of the diaphragm, the volume of the lungsis also increased. As the volume of the lungs increase, the pressure ofthe air in the lungs falls slightly below the pressure of the airexternal to the body (ambient air pressure). Accordingly, as a result ofthis slight pressure differential, external or ambient air flows throughthe respiratory passageways described above and fills the lungs untilthe pressure equalizes. This process is inspiration. When the diaphragmis relaxed, the volume of the thoracic cavity decreases, which in turndecreases the volume of the lungs. As the volume of the lungs decrease,the pressure of the air in the lungs rises slightly above the pressureof the air external to the body. Accordingly, as a result of this slightpressure differential, the air in the alveoli is expelled through therespiratory passageways until the pressure equalizes. This process isexpiration.

[0036] Continued insult to the respiratory system may result in variousdiseases, for example, chronic obstructive pulmonary disease. Chronicobstructive pulmonary disease is a persistent obstruction of the airwayscaused by chronic bronchitis and pulmonary emphysema. In the UnitedStates alone, approximately fourteen million people suffer from someform of chronic obstructive pulmonary disease and it is in the top tenleading causes of death.

[0037] Chronic bronchitis and acute bronchitis share certain similarcharacteristics; however, they are distinct diseases. Both chronic andacute bronchitis involve inflammation and constriction of the bronchialtubes and the bronchioles; however, acute bronchitis is generallyassociated with a viral and/or bacterial infection and its duration istypically much shorter than chronic bronchitis. In chronic bronchitis,the bronchial tubes secrete too much mucus as part of the body'sdefensive mechanisms to inhaled foreign substances. Mucus membranescomprising ciliated cells (hair like structures) line the trachea andbronchi. The ciliated cells or cilia continuously push or sweep themucus secreted from the mucus membranes in a direction away from thelungs and into the pharynx, where it is periodically swallowed. Thissweeping action of the cilia functions to keep foreign matter fromreaching the lungs. Foreign matter that is not filtered by the nose andlarynx, as described above, becomes trapped in the mucus and ispropelled by the cilia into the pharynx. When too much mucus issecreted, the ciliated cells may become damaged, leading to a decreasein the efficiency of the cilia to sweep the bronchial tubes and tracheaof the mucus containing the foreign matter. This in turn causes thebronchioles to become constricted and inflamed and the individualbecomes short of breath. In addition, the individual will develop achronic cough as a means of attempting to clear the airways of excessmucus.

[0038] Individuals who suffer from chronic bronchitis may developpulmonary emphysema. Pulmonary emphysema is a disease in which thealveoli walls, which are normally fairly rigid structures, aredestroyed. The destruction of the alveoli walls is irreversible.Pulmonary emphysema may be caused by a number of factors, includingchronic bronchitis, long term exposure to inhaled irritants, e.g. airpollution, which damage the cilia, enzyme deficiencies and otherpathological conditions. In pulmonary emphysema, the alveoli of thelungs lose their elasticity, and eventually the walls between adjacentalveoli are destroyed. Accordingly, as more and more alveoli walls arelost, the air exchange (oxygen and carbon dioxide) surface area of thelungs is reduced until air exchange becomes seriously impaired. Thecombination of mucus hypersecretion and dynamic airway compression aremechanisms of airflow limitation in chronic obstructive pulmonarydisease. Dynamic airway compression results from the loss of tetheringforces exerted on the airway due to the reduction in lung tissueelasticity. Mucus hypersecretion is described above with respect tobronchitis. In other words, the breakdown of lung tissue leads to thereduced ability of the lungs to recoil and the loss of radial support ofthe airways. Consequently, the loss of elastic recoil of the lung tissuecontributes to the inability of individuals to exhale completely. Theloss of radial support of the airways also allows a collapsingphenomenon to occur during the expiratory phase of breathing. Thiscollapsing phenomenon also intensifies the inability for individuals toexhale completely. As the inability to exhale completely increases,residual volume in the lungs also increases. This then causes the lungto establish in a hyperinflated state where an individual can only takeshort shallow breaths. Essentially, air is not effectively expelled andstale air accumulates in the lungs. Once the stale air accumulates inthe lungs, the individual is deprived of oxygen. There is no cure forpulmonary emphysema, only various treatments, including exercise, drugtherapy, such as bronchodilating agents, lung volume reduction surgeryand long term oxygen therapy.

[0039] As described above, long term oxygen therapy is widely acceptedas the standard treatment for hypoxia caused by chronic obstructivepulmonary disease. Typically, oxygen therapy is prescribed using a nasalcannula. There are disadvantages associated with using the nasalcannula. One disadvantage associated with utilizing nasal cannula is thesignificant loss of oxygen between the cannula and the nose, which inturn equates to more frequent changes in the oxygen source, or higherenergy requirements to generate more oxygen. Another disadvantageassociated with utilizing nasal cannula is the fact that the cannulasmay cause the nasal passages to become dry, cracked and sore.

[0040] Transtracheal oxygen therapy has become a viable alternative tolong term oxygen therapy. Transtracheal oxygen therapy delivers oxygendirectly to the lungs using a catheter that is placed through and downthe trachea. Due to the direct nature of the oxygen delivery, a numberof advantages are achieved. These advantages include lower oxygenrequirements due to greater efficiency, increased mobility, greaterexercise capability and improved self image.

[0041] The long term oxygen therapy system and method of the presentinvention may be utilized to deliver oxygen directly into the lungtissue in order to optimize oxygen transfer efficiency in the lungs. Inother words, improved efficiency may be achieved if oxygen were to bedelivered directly into the alveolar tissue in the lungs. In emphysema,alveoli walls are destroyed, thereby causing a decrease in air exchangesurface area. As more alveoli walls are destroyed, collateralventilation resistance is lowered. In other words, pulmonary emphysemacauses an increase in collateral ventilation and to a certain extent,chronic bronchitis also causes an increase in collateral ventilation.Essentially, in an emphysematous lung, the communicating flow of airbetween neighboring air sacs (alveoli), known as collateral ventilation,is much more prevalent as compared to a normal lung. Since air cannot beexpelled from the native airways due to the loss of tissue elasticrecoil and radial support of the airways (dynamic collapse duringexhalation), the increase in collateral ventilation does notsignificantly assist an individual in breathing. The individual developsdsypnea. Accordingly, if it can be determined where collateralventilation is occurring, then the diseased lung tissue may be isolatedand the oxygen delivered to this precise location or locations. Variousmethods may be utilized to determine the diseased tissue locations, forexample, computerized axial tomography or CAT scans, magnetic resonanceimaging or MRI, positron emission tomograph or PET, and/or standardX-ray imaging. Once the diseased tissue is located, pressurized oxygenmay be directly delivered to these diseased areas and more effectivelyand efficiently forced into the lung tissue for air exchange.

[0042]FIG. 1 illustrates a first exemplary long term oxygen therapysystem 100. The system 100 comprises an oxygen source 102, an oxygencarrying conduit 104 and a one-way valve 106. The oxygen source 102 maycomprise any suitable device for supplying filtered oxygen underadjustably regulated pressures and flow rates, including pressurizedoxygen tanks, liquid oxygen reservoirs, oxygen concentrators and theassociated devices for controlling pressure and flow rate e.g.regulators. The oxygen carrying conduit 104 may comprise any suitablebiocompatible tubing having a high resistance to damage caused bycontinuous oxygen exposure. The oxygen carrying conduit 104 comprisestubing having an inside diameter in the range from about {fraction(1/16)} inch to about ½ inch and more preferably from about ⅛ inch toabout ¼ inch. The one-way valve 106 may comprise any suitable, in-linemechanical valve which allows oxygen to flow into the lungs 108 throughthe oxygen carrying conduit 104, but not from the lungs 108 back intothe oxygen source 102. For example, a simple check valve may beutilized. As illustrated in FIG. 1, the oxygen carrying conduit 104passes through the lung 108 at the site determined to have the highestdegree of collateral ventilation.

[0043] The exemplary system 100 described above may be modified in anumber of ways, including the use of an in-line filter. In thisexemplary embodiment, both oxygen and air may flow through the system.In other words, during inhalation, oxygen is delivered to the lungsthrough the oxygen carrying conduit 104 and during exhalation, air fromthe lungs flow through the oxygen carrying conduit 104. The in-linefilter would trap mucus and other contaminants, thereby preventing ablockage in the oxygen source 102. In this exemplary embodiment, novalve 106 would be utilized.

[0044] In order for the exemplary long term oxygen therapy system 100 tofunction, an air tight seal is preferably maintained where the oxygencarrying conduit 104 passes through the thoracic cavity and lung. Thisseal is maintained in order to sustain the inflation/functionality ofthe lungs. If the seal is breached, air can enter the cavity and causethe lungs to collapse as described above.

[0045] A method to create this seal comprises forming adhesions betweenthe visceral pleura of the lung and the inner wall of the thoraciccavity. This may be achieved using either chemical methods, includingirritants such as Doxycycline and/or Bleomycin, surgical methods,including pleurectomy or thoracoscopic talc pleurodesis, or radiotherapymethods, including radioactive gold or external radiation. All of thesemethods are known in the relevant art for creating pleurodesis. With aseal created at the site for the ventilation bypass, an intervention maybe safely performed without the danger of creating a pneumothorax of thelung.

[0046] Similarly to ostomy pouches or bags, the oxygen carrying conduit104 may be sealed to the skin at the site of the ventilation bypass. Inone exemplary embodiment, illustrated in FIG. 2, the oxygen carryingconduit 104 may be sealed to the skin of the thoracic wall utilizing anadhesive. As illustrated, the oxygen carrying conduit 104 comprises aflange 200 having a biocompatible adhesive coating on the skincontacting surface. The biocompatible adhesive would provide a fluidtight seal between the flange 200 and the skin or epidermis of thethoracic wall. In a preferred embodiment, the biocompatible adhesiveprovides a temporary fluid tight seal such that the oxygen carryingconduit 104 may be disconnected from the ventilation bypass site. Thiswould allow for the site to be cleaned and for the long term oxygentherapy system 100 to undergo periodic maintenance.

[0047]FIG. 3 illustrates another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall at the siteof the ventilation bypass. In this exemplary embodiment, a couplingplate 300 is sealed to the skin at the site of the ventilation bypass bya biocompatible adhesive coating or any other suitable means. The oxygencarrying conduit 104 is then connected to the coupling plate 300 by anysuitable means, including threaded couplings and locking rings. Theexemplary embodiment also allows for cleaning of the site andmaintenance of the system 100.

[0048]FIG. 4 illustrates yet another exemplary embodiment for sealingthe oxygen carrying conduit 104 to the skin of the thoracic wall at thesite of the ventilation bypass. In this exemplary embodiment, balloonflanges 400 may be utilized to create the seal. The balloon flanges 400may be attached to the oxygen carrying conduit 104 such that in thedeflated state, the oxygen carrying conduit 104 and one of the balloonflanges passes through the ventilation bypass anastomosis. The balloonflanges 400 are spaced apart a sufficient distance such that the balloonflanges remain on opposite sides of the thoracic wall. When inflated,the balloons expand and form a fluid tight seal by sandwiching thethoracic wall. Once again, this exemplary embodiment allows for easyremoval of the oxygen carrying conduit 104.

[0049]FIG. 5 illustrates yet another exemplary embodiment for sealingthe oxygen carrying conduit 104 to the skin of the thoracic wall at thesite of the ventilation bypass. In this exemplary embodiment, a singleballoon flange 500 is utilized in combination with a fixed flange 502.The balloon flange 500 is connected to the oxygen carrying conduit 104in the same manner as described above. In this exemplary embodiment, theballoon flange 500, when inflated, forms the fluid tight seal. The fixedflange 502, which is maintained against the skin of the thoracic wall,provides the structural support against which the balloon exertspressure to form the seal.

[0050] If an individual has difficulty exhaling and requires additionaloxygen, collateral ventilation bypass may be combined with direct oxygentherapy. FIG. 6 illustrates an exemplary embodiment of a collateralventilation bypass/direct oxygen therapy system 600. The system 600comprises an oxygen source 602, an oxygen carrying conduit 604 havingtwo branches 606 and 608, and a control valve 610. The oxygen source 602and oxygen carrying conduit 604 may comprise components similar to theabove-described exemplary embodiment illustrated in FIG. 1. In thisexemplary embodiment, when the individual inhales, the valve 610 is openand oxygen flows into the lung 612 and into the bronchial tube 614. Inan alternate exemplary embodiment, the branch 608 may be connected tothe trachea 616. Accordingly, during inhalation oxygen flows to thediseased site in the lung or lungs and to other parts of the lungthrough the normal bronchial passages. During exhalation, the valve 610is closed so that no oxygen is delivered and air in the diseased portionof the lung may flow from the lung 612, through one branch 606 and intothe second branch 608 and finally into the bronchial tube 616. In thismanner, stale air is removed and oxygen is directly delivered.

[0051] The connection and sealing of the oxygen carrying conduit 604 andbranches 606, 608 to the lung 612 and bronchial tube 614 may be made ina manner similar to that described above.

[0052] The above-described long term oxygen therapy system may beutilized to effectively treat hypoxia caused by chronic obstructivepulmonary disease; however, other means may be desirable to treat otheraspects of the disease. As set forth above, emphysema is distinguishedas irreversible damage to lung tissue. The breakdown of lung tissueleads to the reduced ability for the lungs to recoil. The tissuebreakdown also leads to the loss of radial support of the nativeairways. Consequently, the loss of elastic recoil of the lung tissuecontributes to the inability for individuals with emphysema to exhalecompletely. The loss of radial support of the native airways also allowsa collapsing phenomenon to occur during the expiratory phase ofbreathing. This collapsing phenomenon also intensifies the inability forindividuals to exhale completely. As the inability to exhale increases,residual volume in the lungs also increases. This then causes the lungto establish in a hyperinflated state wherein an individual can onlytake short shallow breaths.

[0053] The collateral ventilation bypass trap system of the presentinvention utilizes the above-described collateral ventilation phenomenonto increase the expiratory flow from a diseased lung or lungs, therebytreating another aspect of chronic obstructive pulmonary disease.Essentially, the most collaterally ventilated area of the lung or lungsis determined utilizing the scanning techniques described above. Oncethis area or areas are located, a conduit or conduits are positioned ina passage or passages that access the outer pleural layer of thediseased lung or lungs. The conduit or conduits utilize the collateralventilation of the lung or lungs and allows the entrapped air to bypassthe native airways and be expelled to a containment system outside ofthe body.

[0054]FIG. 7 illustrates a first exemplary collateral ventilation bypasstrap system 700. The system 700 comprises a trap 702, an air carryingconduit 704 and a filter/one-way valve 706. The air carrying conduit 704creates a fluid communication between an individual's lung 708 and thetrap 702 through the filter/one-way valve 706. It is important to notethat although a single conduit 704 is illustrated, multiple conduits maybe utilized in each lung 708 if it is determined that there are morethan one area of high collateral ventilation.

[0055] The trap 702 may comprise any suitable device for collectingdischarge from the individual's lung or lungs 708. Essentially, the trap702 is simply a containment vessel for temporarily storing dischargefrom the lungs, for example, mucous and other fluids that may accumulatein the lungs. The trap 702 may comprise any suitable shape and may beformed from any suitable metallic or non-metallic materials. Preferably,the trap 702 should be formed from a lightweight, non-corrosivematerial. In addition, the trap 702 should be designed in such a manneras to allow for effective and efficient cleaning. In one exemplaryembodiment, the trap 702 may comprise disposable liners that may beremoved when the trap 702 is full. The trap 702 may be formed from atransparent material or comprise an indicator window so that it may beeasily determined when the trap 702 should be emptied or cleaned. Alightweight trap 702 increases the patient's mobility.

[0056] The filter/one-way valve 706 may be attached to the trap 702 byany suitable means, including threaded fittings or compression typefittings commonly utilized in compressor connections. The filter/one-wayvalve 706 serves a number of functions. The filter/one-way valve 706allows the air from the individual's lung or lungs 708 to exit the trap702 while maintaining the fluid discharge and solid particulate matterin the trap 702. This filter/one-way valve 706 would essentiallymaintain the pressure in the trap 702 below that of the pressure insidethe individual's lung or lungs 708 so that the flow of air from thelungs 708 to the trap 702 is maintained in this one direction. Thefilter portion of the filter/one-way valve 706 may be designed tocapture particulate matter of a particular size which is suspended inthe air, but allows the clean air to pass therethrough and be vented tothe ambient environment. The filter portion may also be designed in sucha manner as to reduce the moisture content of the exhaled air.

[0057] The air carrying conduit 704 connects the trap 702 to the lung orlungs 708 of the patient through the filter/one-way valve 706. The aircarrying conduit 704 may comprise any suitable biocompatible tubinghaving a resistance to the gases contained in air. The air carryingconduit 704 comprises tubing having an inside diameter in the range fromabout {fraction (1/16)} inch to about ½ inch, and more preferably fromabout ⅛ inch to about ¼ inch. The filter/one-way valve 706 may compriseany suitable valve which allows air to flow from the lung or lungs 708through the air carrying conduit 704, but not from the trap 702 back tothe lungs 708. For example, a simple check valve may be utilized. Theair carrying conduit 704 may be connected to the filter/one-way valve706 by any suitable means. Preferably, a quick release mechanism isutilized so that the trap may be easily removed for maintenance. Asillustrated in FIG. 7, the air carrying conduit 704 passes through thelung 708 at the site determined to have the highest degree of collateralventilation. If more than one site is determined, multiple air carryingconduits 704 may be utilized. The connection of multiple air carryingconduits 704 to the filter/one-way valve 706 may be accomplished by anysuitable means, including an octopus device similar to that utilized inscuba diving regulators.

[0058] The air carrying conduit 704 is preferably able to withstand andresist collapsing once in place. Since air will travel through theconduit 704, if the conduit is crushed and unable to recover, theeffectiveness of the system is diminished. Accordingly, a crushrecoverable material may be incorporated into the air carrying conduit704 in order to make it crush recoverable. Any number of suitablematerials may be utilized. For example, Nitinol incorporated into theconduit 704 will give the conduit collapse resistance and collapserecovery properties.

[0059] Expandable features at the end of the conduit 704 may be used toaid in maintaining contact and sealing the conduit 704 to the lungpleura. Nitinol incorporated into the conduit 704 will provide theability to deliver the conduit 704 in a compressed state and thendeployed in an expanded state to secure it in place. Shoulders at theend of the conduit may also provide a mechanical stop for insertion andan area for an adhesive/sealant to join as described in detailsubsequently.

[0060] In order for the exemplary collateral ventilation bypass trapsystem 700 to function, an air tight seal is preferably maintained wherethe air carrying conduit 704 passes through the thoracic cavity andlungs 708. This seal is maintained in order to sustain theinflation/functionality of the lungs. If the seal is breached, air canenter the cavity and cause the lungs to collapse. One exemplary methodfor creating the seal comprises forming adhesions between the visceralpleura of the lung and the inner wall of the thoracic cavity. This maybe achieved using either chemical methods, including irritants such asDoxycycline and/or Bleomycin, surgical methods, including pleurectomy orthorascopic talc pleurodesis, or radiotherapy methods, includingradioactive gold or external radiation. All of these methods are knownin the relevant art for creating pleurodesis. In another alternateexemplary embodiment, a sealed joint between the air carrying conduit704 and the outer pleural layer includes using various glues to helpwith the adhesion/sealing of the air carrying conduit 704. Currently,Focal Inc. markets a sealant available under the tradename Focal/Seal-Lwhich is indicated for use on a lung for sealing purposes. Focal/Seal-Lis activated by light in order to cure the sealant. Another sealavailable under the tradename Thorex, which is manufactured by SurgicalSealants Inc., is currently conducting a clinical trial for lung sealingindications. Thorex is a two-part sealant that has a set curing timeafter the two parts are mixed.

[0061] The creation of the opening in the chest cavity may beaccomplished in a number of ways. For example, the procedure may beaccomplished using an open chest procedure, aternotomy or thoracotomy.Alternately, the procedure may be accomplished using a laproscopictechnique, which is less invasive. Regardless of the procedure utilized,the seal should be established while the lung is at least partiallyinflated in order to maintain a solid adhesive surface. The opening maythen be made after the joint has been adequately created between theconduit component and the lung pleural surface. The opening should beadequate in cross-sectional area in order to provide sufficientdecompression of the hyperinflated lung. This opening, as stated above,may be created using a number of different techniques such as cutting,piercing, dilating, blunt dissection, radio frequency energy, ultrasonicenergy, microwave energy, or cryoblative energy.

[0062] The air carrying conduit 704 may be sealed to the skin at thesite by any of the means and methods described above with respect to theoxygen carrying conduit 704 and illustrated in FIGS. 2 through 5.

[0063] In operation, when an individual exhales, the pressure in thelungs is greater than the pressure in the trap 702. Accordingly, the airin the highly collaterilized areas of the lung will travel through theair carrying conduit 704 to the trap 702. This operation will allow theindividual to more easily and completely exhale.

[0064] Although shown and described is what is believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific designs and methods described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

What is claimed is:
 1. A collateral ventilation bypass trap systemcomprising: a containment vessel for collecting discharge from one ormore lungs of a patient; at least one conduit having a first endconnected to the containment vessel and a second end passing through thethoracic wall and lung of a patient at a predetermined site, therebyestablishing fluid communication between the containment vessel and theinner volume of the lung; and a sealing device for establishing a fluidtight seal between the at least one conduit and the thoracic wall andbetween the at least one conduit and the lung.
 2. A collateralventilation bypass trap system comprising: a containment vessel forcollecting discharge from one or more lungs of a patient; afilter/one-way valve connected to the containment vessel; at least oneconduit having a first end connected to the containment vessel throughthe filter one-way valve and a second end passing through the thoracicwall and lung of a patient at a predetermined site, thereby establishingfluid communication between the containment vessel and the inner volumeof the lung; and a sealing device for establishing a fluid tight sealbetween the at least one conduit and the thoracic wall and between theat least one conduit and the lung.
 3. A method for increasing theexpiratory flow from a diseased lung, the method comprising: creating ananastomotic opening extending from the thoracic wall and into the innervolume of the lung at a site determined to have a high degree ofcollateral ventilation; establishing a fluid communication link betweenthe inner volume of the lung at the site determined to have a highdegree of collateral ventilation and a containment vessel through aconduit extending from the containment vessel to the lung through theanastomotic opening such that air in the lung flows into the containmentvessel; and establishing a fluid tight seal between the anastomoticopening and the conduit.